GASBTX: Goal Attainment Scaling in Upper Limb Spasticity Treatment

Sponsor

University Rehabilitation Institute, Republic of Slovenia (Other)

Overall Status

Recruiting

CT.gov ID

NCT04975646

Collaborator

(none)

Enrollment

Location

Arms

22.9

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients after stroke with upper limb spasticity treated with botulinum toxin-A (BTX-A) will be included in this two-part study. In the first part, goal attainment scaling and comprehensive assessment of motor functioning will be performed before BTX-A application and after two weeks. In the second part, the patients will be randomised into a test group performing prescribed regular exercise for two weeks and a control group exercising at their own discretion during the same period, whereby the patients' health-related quality of life will be assessed at the beginning and end of the two-week period.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke Hemorrhagic Stroke	Behavioral: Prescribed exercise program	N/A

Detailed Description

Goal setting will be performed by the patient together with the physician according to the SMART principle (specific, measureable, achievable, realistic, time bound). The goals will be classified according to the International Classification of Functioning, Disability and Health. Goal attainment will be assessed using the Goal Attainment Scale - Light. Comprehensive assessment of motor functioning will address range of motion, spasticity, pain, degree of motor disability and degree of dependence in daily activities. The prescribed exercises for the test group will be passive or active, depending on spasticity of the impaired upper limb. Both groups will keep an Exercise Diary during the second part of the study.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

First part: observational study. Second part: parallel groups.First part: observational study. Second part: parallel groups.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Goal Attainment Scaling in Upper Limb Spasticity Treatment With Botulinum Toxin and the Influence of Regular Exercise for Spastic Upper Limb on Quality of Life in Patients After Stroke

Actual Study Start Date :

Jan 3, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test group Prescribed exercise program	Behavioral: Prescribed exercise program Active or passive exercises for the spastic upper limb, including functional electrical stimulation (FES), performed regularly for two weeks.
No Intervention: Control group Exercising at patient's own discretion

Arm

Intervention/Treatment

Experimental: Test group

Prescribed exercise program

Behavioral: Prescribed exercise program

Active or passive exercises for the spastic upper limb, including functional electrical stimulation (FES), performed regularly for two weeks.

No Intervention: Control group

Exercising at patient's own discretion

Outcome Measures

Primary Outcome Measures

GAS-Light [At baseline, after 2 weeks (i.e., at the end of the 1st part of the study)]
Change in Goal Attainment Scale - Light
SQoL-6D [Start of the 2nd part of the study (i.e., after 2 weeks), end of the 2nd part of the study (i.e., after 4 weeks)]
Change in Spasticity Related Quality of Life Tool score

Secondary Outcome Measures

ROM [Start of the 2nd part of the study (i.e., after 2 weeks), end of the 2nd part of the study (i.e., after 4 weeks)]
Change in Range of motion (degrees)
MAS [Start of the 2nd part of the study (i.e., after 2 weeks), end of the 2nd part of the study (i.e., after 4 weeks)]
Change in Modified Ashworth Scale score
PSFS [Start of the 2nd part of the study (i.e., after 2 weeks), end of the 2nd part of the study (i.e., after 4 weeks)]
Difference in Penn Spasm Frequency Scale
VAS [Start of the 2nd part of the study (i.e., after 2 weeks), end of the 2nd part of the study (i.e., after 4 weeks)]
Change in pain rating on the Visual Analog Scale
BSR [Start of the 2nd part of the study (i.e., after 2 weeks), end of the 2nd part of the study (i.e., after 4 weeks)]
Change in Brunnstrom Stage of Recovery score
MRS [Start of the 2nd part of the study (i.e., after 2 weeks), end of the 2nd part of the study (i.e., after 4 weeks)]
Change in Modified Rankin Scale score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patient's or caregiver's approval
ischemic or hemorrhagic stroke diagnosed using head CT/MRI
at least one upper limb muscle spasticity (MAS ≥ 3)
candidate for BTX-A treatment or already given BTX-A in the past
patient's or caregiver's capability for goal attainment protocol cooperation (Mini Mental Examination ≥ 24 points)